Formaldehyde

Overview

In June 2010, EPA released an external review draft of the formaldehyde reassessment for public review and comment. The IRIS Toxicological Review of Formaldehyde (Inhalation) provides scientific support and rationale for the hazard and dose-response assessment pertaining to chronic inhalation exposure to formaldehyde.

Then in 2014, EPA began revising its assessment to address the 2011 NAS peer review recommendations (see related links). This assessment addresses both noncancer and cancer human health effects that are relevant to assessing the risks from chronic inhalation exposure to formaldehyde. To facilitate discussion of several scientific issues pertinent to the assessment, EPA convened a public workshop held on April 30 and May 1, 2014. This workshop focused on the following three themes:

• Evidence pertaining to the influence of formaldehyde that is produced endogenously (by the body during normal biological processes) on the toxicity of inhaled formaldehyde, and implications for the health assessment;
• Mechanistic evidence relevant to formaldehyde inhalation exposure and lymphohematopoietic cancers (leukemia and lymphomas); and
• Epidemiological research examining the potential association between formaldehyde exposure and lymphohematopoietic cancers (leukemia and lymphomas).

Background

The draft toxicological review of formaldehyde - inhalation assessment provides scientific support and rationale for the hazard and dose-response assessment pertaining to chronic inhalation exposure to formaldehyde. Formaldehyde is present in a wide variety of products including some plywood adhesives, abrasive materials, insulation, insecticides and embalming fluids. The major sources of anthropogenic emissions of formaldehyde are motor vehicle exhaust, power plants, manufacturing plants that produce or use formaldehyde or substances that contain it (i.e. glues), petroleum refineries, coking operations, incinerating, wood burning and tobacco smoke.

History/Chronology

Date	Description
Sep 1990	The oral RfD for formaldehyde was posted to the IRIS database.
May 1991	The cancer assessment for formaldehyde was posted to the IRIS database.
Jan 1998	EPA begins the formaldehyde reassessment under the IRIS Program.
May 2010	EPA initiated an interagency science consultation on the review of the draft Toxicological Review of formaldehyde.
Jun 2010	EPA released an external review draft of the formaldehyde reassessment for public review and comment. Also released was the interagency review draft with comments.
Jun 2010	On Jun 7-8, 2010 in Washington DC, EPA conducted an independent expert peer review by the National Academy of Sciences and public comment of the scientific basis supporting the human health hazard and dose-response assessment of Formaldehyde-Inhalation that when finalized will appear on the Integrated Risk Information System (IRIS) database. This draft IRIS health assessment addresses both noncancer and cancer human health effects that may result from chronic inhalation exposure to this chemical.
Jul 2010	NAS held their second external review meeting to discuss the draft report on July 6, 2010.
Aug 2010	NAS held their third external review meeting to discuss the draft report on Aug 9-10, 2010 in Washington, DC.
Oct 2010	NAS held their fourth external review meeting to discuss the draft report on Oct 12-13, 2010 in Washington, DC.
Dec 2010	NAS held their fifth and final external review meeting to discuss the draft report on Dec 13-14, 2010 in Los Angelos, CA.
May 2011	NAS's Board on Environmental Studies and Toxicology (BEST) releases the NAS Review of the Environmental Protection Agency's Draft IRIS Assessment of Formaldehyde (Final Report).

Status

An updated timeline will be posted in the June 2021 IRIS Program Outlook.

Additional Information

In 2019, EPA announced the release of the Toxicological Review of Formaldehyde-Inhalation Assessment in a June 2, 2010 Federal Register Notice. This draft assessment was provided for public viewing and comment. Public comments received on the Toxicological Review within 90 days after the release of the FRN were provided to the National Academy of Sciences (NAS) independent scientific peer review committee for its consideration. Any comments not received within the requested time period will be considered by EPA in revisions. This FRN also includes notice of a public listening session that was held on July 27, 2010.

This download(s) is distributed solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. It has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency determination or policy.

• Toxicological Review of Formaldehyde-Inhalation Assessment: In Support of Summary Information on the Integrated Risk Information System (IRIS) (PDF)  (1043  pp, 7.6 MB, about PDF)
• Tox Review of Formaldehyde, Volume 1: Introduction, Background, and Toxicokinetics (PDF)  (112  pp, 1.1 MB, about PDF)
• Tox Review of Formaldehyde, Volume 2: Hazard Characterization (PDF)  (570  pp, 4.1 MB, about PDF)
• Tox Review of Formaldehyde, Volume 3: Quantitative Assessment, Major Conclusions in the Characterization of Hazard and Dose Response, and References (PDF)  (253  pp, 1.5 MB, about PDF)
• Tox Review of Formaldehyde, Volume 4: Appendices (PDF)  (108  pp, 1.0 MB, about PDF)
• Charge to the NAS Panel (PDF)  (2  pp, 23.4 KB, about PDF)
• Agency Response to Formaldehyde 2010 ERD (PDF)  (NA  pp, 28.3 KB, about PDF)

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Document Related Link(s)

• NAS: Review of EPA's Draft IRIS Assessment of Formaldehyde (Project Overview)
• NAS Public Review Mtg Announcement: Jun 7-8, 2010
• Press Release: EPA Releases Draft Formaldehyde Assessment Report for Peer Review and Public Comment
• NAS Review of the Environmental Protection Agency's Draft IRIS Assessment of Formaldehyde (Final Report)
• IRIS Toxicological Review of Formaldehyde (Interagency Science Consultation Draft, 2010)
• IRIS Program Outlook April 2019-Suspended/Discontinued Assessment

Federal Register Notices

• Press Release: Jun 1, 2010
• FR Notice: Jun 2, 2010